Randomized, Open, Parallel, Active Controlled Study on Fracture Prevention in Antiosteoporosis Treatment (OF Study)

NCT00165607 | Completed Phase 4

• 1 other identifier: GA001R00
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate a new incidence and preventive effect of menatetrenone on vertebral fracture in patients with osteoporosis who were randomly assigned to either treatment arm receiving daily dose of calcium supplement as a monotherapy (calcium monotherapy group) or menatetrenone plus calcium supplement as a combination therapy (menatetrenone combo therapy group) for 36 months, followed by a 12-month follow-up observation to examine the preventive effect on the fracture risk.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• New incidence of vertebral fracture at 36 months. vertebral fracture is morphological transformation.

Secondary Outcomes (1)

• New incidence of clinical fracture (upper forelimb, femur, radius, and vertebral fracture associated with severe trauma that can cause fracture in normal bones of young adults) at 48 months

Interventions

MENATETRANONE DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatient or outpatient is not asked. If using any anti-osteoporotic agent other than calcium preparations (i.e., contraindicated for concomitant use stipulated in the protocol of this post-marketing study), such agent must be discontinued. Even after the discontinuation, calcium dosing is permitted with a condition that the subsequent use is started after a 8-week elapse from the discontinuation.
• Patients with primary osteoporosis (diagnosed according to "Diagnostic Criteria for Primary Osteoporosis issued by the Japanese Society for Bone and Mineral Research (1995)."
• Post-menopausal patients aged 50 years or older.
• Patients who agree to participate in a 4-year follow-up observation.
• Patients who provide written informed consent.
• Patients on warfarin potassium (Warfarin®) therapy.
• Patients with hypercalcemia.
• Patietns with renal calculus.
• Patients with a known history of hypersensitivity to calcium or menatetrenone preparations.
• Patients with severe complication in the hepatic, renal, gastrointestinal, cardio- and cerebrovascular system.
• Patients who underwent bilateral ovariectomy.
• Patients with radiotherapy in the pelvis or para-aortic area.
• Patients with the following X-ray findings;
• Patients showing osteophytes connecting with adjacent vertebral osteophytes
• Patients showing hyperostosis of ligament around the vertebral body

Sponsors & Collaborators

• Eisai Limited: lead

Study Sites (1)

Unknown Facility

Ōmura, Nagasaki, 856-0835, Japan

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Norio Iinuma

  Post-Marketing Clinical Research Department. Clinical Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: April 1, 1996
• Primary Completion: June 1, 2005
• Last Updated: January 29, 2010

Record last verified: 2010-01

Locations

JP (1)